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临床试验/CTRI/2021/01/030822
CTRI/2021/01/030822尚未招募2 期

Dexmeditomedine Vs Morphine infusion for sedation in mechanically ventilated Term Neonates

JSS Medical College1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年1月2日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Time to achieve pin relief in the first 24 hrs of commencing ventilation and hemodynamical stability during the study period

研究概览

简要总结

Newborn babies require intensive care for various reasons**.**Mechanical ventilation is one of the modes of treatment. It is associated with pain and hence agitation resulting in ventilation dysynchrony. Pain can have impact on the vital parameters and also can have long term morbidities. Hence, Pain relief and in some cases, sedation is necessary to optimize care for critically ill babies and also to facilitate gas exchange. Opioids such as morphine or fentanyl are the commonly used pain relief and sedation as first line in neonatal intensive care units.

However, these drugs can result in substantial respiratory depression, decreased gastrointestinal motility and hypotension due to vasodilatation. All these effects are seen even at lower therapeutic doses. These adverse effects may lead to prolonged duration of ventilation, hospital stay and eventually increased morbidity. Hence, there a need for a newer drug to have a fine balance between achieving comfort without much of side effect.

Dexmeditomedine is a centrally active alpha receptor agonist having both sedative and analgesic properties. There is evidence to suggest that dexmeditomedine has lesser respiratory depression, no GI side effects and also promotes macrophage activity thereby reducing the sepsis.

This study was aimed at comparing the Dexmeditomedine infusion with morphine for sedation and pain relief in term ventilated babies.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
0.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • All term neonates admitted in Neonatal Intensive care requiring Mechanical ventilation.

排除标准

  • Babies less 36 weeks of gestation, Term babies with Sarnat stage 2.

结局指标

主要结局

Time to achieve pin relief in the first 24 hrs of commencing ventilation and hemodynamical stability during the study period

时间窗: Time to achieve pin relief in the first 24 hrs of commencing ventilation and hemodynamical stability during the study period

次要结局

  • hemodynamic instability interns of bradycardia and hypotension needing inotropes(within 24 hrs)

研究者

申办方类型
Private medical college

研究点 (1)

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